Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery

Not Applicable

• Conditions: Refractive Errors
• Interventions: Device: ReLex Smile

• Registration Number: NCT04793893
• Lead Sponsor: Eye Hospital Pristina Kosovo

Brief Summary

LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.

Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)

Detailed Description

The main problem at young patients post - LASIK after one year is residual refractive errors.

The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).

1. The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.

2. The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.

Study Timeline

• Study Start: 2019-01-08
• Primary Completion: 2020-01-08
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Study Completion: 2025-11-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• residual hypermetropic refraction,
• low visual acuity

Exclusion Criteria

• active anterior segment pathology,
• glaucoma,
• retinae detachment,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of residual hypermetropia refraction after LASIK	ReLex Smile	The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D). The flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap.

Primary Outcome Measures

Name	Time	Method
Increase of visual acuity	12 months	Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo